The Hong Kong Association of the Pharmaceutical Industry Issue 10 /12 2015
In This Issue
HKAPI Joint Meeting with the Drug Office
Seminar on the New Patent Linkage System in Hong Kong and its Implications
Seminar on New Anti-competition Guideline and its Impact on the Pharmaceutical Industry
HKAPI Training Course Graduation Ceremony 2015
Talk on Internship Program to HKU and CUHK
Oct-Dec 2015
HKAPI Joint Meeting with the Drug Office On 15 December, the Drug Office and HKAPI organized a joint meeting to brief members the implementation details of various regulatory changes, in particular those regulations that will be effective from January 2016. Pharmacists from the Drug Office first explained the PIC/S GMP requirements for registration and renewal of pharmaceutical products. Also, the final guidance notes for the registration of biosimilar products were endorsed by the Pharmacy and Poisons Board and will be effective on 1 January 2016. On the registration condition of pharmaceutical products, applicants submitting an application for pharmaceutical products are required to make a patent declaration that the product does not infringe the patent rights of other registered products and it will be suspended for sale or deregistered by the Registration Committee if found to contravene patent rights. Apart from the above, sales control of pharmaceutical products for human parenteral use will be strengthened and become effective in August 2016. Last but not least, the draft general requirements for master formula and specifications for non-biological products and the review of regulatory control for Glucosamine and Vitamins were discussed. About 100 members attended the meeting and the Association is glad to have the opportunity to understand these important regulatory changes and members can clarify their queries with the Drug Office.
HKAPI Bowling Cup 2015
HKAPI Cup (Basketball) 2015 Finals
Editorial Board Sabrina Chan
Mr. Frank Chan, Chief Pharmacist of the Drug
Ms. Sabrina Chan, Executive Director of
Office, welcomed HKAPI members to join the
HKAPI, explained the objectives of the joint
meeting.
meeting.
Panelists from Drug Office at the Q&A section
Mr. Clive Chan further explained the details of
(From Left to Right): Mr. Clive Chan (Senior
regulatory changes.
Pharmacist), Mr. Frank Chan (Chief Pharmacist), Jenny Wan
Mr. YL Mak (Senior Pharmacist).
Contact Us Tel: 2528-3061 Fax: 2865-6283 http://www.hkapi.hk/ Email:
[email protected]
Participants took the opportunity to clarify their
About 100 representatives from our member
queries.
companies attended the joint meeting.
Seminar on the New Patent Linkage System in Hong Kong and its Implications Effective from 1st January 2016, the Drug Office of Hong Kong is imposing new drug registration requirement where applicant of new drug registration needs to make a non-infringement patent declaration. In view of the above, Dechert, HKAPI’s Associate Member, hosted a joint-seminar with the Association on 9th
December to provide an overview of the requirements, the potential impact to the pharmaceutical market in Hong Kong and how different players may be affected. Mr. Lewis Ho, Partner of Dechert, first introduced the new registration conditions, the potential liabilities of the declarant in making the non-infringement declaration as well as the retrospective effect to currently registered drugs and drugs under renewal. How patent owner can enforce their rights under the new regime and the pros and cons of different approaches were then discussed. A case study was used to explain the impact of the new requirement to enable the audience to have a better understanding of the change in regulation. Over 50 members attended the seminar to learn about the impact of the new patent linkage system.
Mr. Lewis Ho, Partner of Dechert, discussed in
Over 50 members attended the seminar on
details the potential liabilities and impact of the
patent linkage.
patent declaration requirements.
Seminar on New Anti-competition Guideline and its Impact on the Pharmaceutical Industry The Hong Kong Competition Ordinance has taken full effect on 14 December 2015 where the substantive provisions has come into force and all firms operating in Hong Kong are required to comply with them. Linklaters, HKAPI’s Associate Member, very timely organized a seminar on the new anti-competition guidelines for our members to understand the impact on the pharmaceutical industry. Partners from Linklater’s competition team in Hong Kong, China and Europe spoke at the seminar, Ms. Clara Ingen-Housz from Hong Kong gave an update on the latest developments in relation to the various Guidelines, enforcement policy as well as leniency policy published by the Competition Commission and their impact on the healthcare industry. Ms. Fay Zhou, Partner from China discussed
the recent crack-down on the industry and the significance of the new antitrust guidelines. Mr. Gavin Robert, Consultant from London also shared with the audience the development of new theories of harm in Europe and their relevance in Asia. Members found the roundtable discussion very informative which enables them to better adapt to the new competition law.
HKAPI Training Course Graduation Ceremony 2015 (Click here for more photos) With a high passing rate of 97 percent, 63 medical representatives from member companies including one student with distinction, successfully completed and graduated from the HKAPI training program. A graduation ceremony was held on 14th December to honour their dedication to continued learning. HKAPI is delighted to have Ms. Linda Woo, Assistant Director (Drug), Department of Health and Professor Joan Zuo, Director and Professor of the Pharmacy School of the Chinese University of Hong Kong to share their views on the important qualities that constitute professionals in the pharmaceutical industry and present the certificates to the graduates. This year, Ms. Carmen Tsui from Kyowa Hakko Kirin graduated with distinction and 25 students obtained credits.
Mrs. Margaret Rumpf, Vice President of
Ms. Linda Woo, Assistant Director (Drug),
the HKAPI, gave the opening remarks at
Department of Health, congratulated the
the graduation ceremony.
graduates on their achievement.
Professor Joan Zuo, Director and Professor of
Ms Carmen Tsui from Kyowa Hakko Kirin
CUHK
graduated with distinction and received the
School
of
Pharmacy,
gave
graduates some words of encouragement.
our
certificate from Mrs. Margaret Rumpf.
Mrs. Margaret Rumpf thanked the class
63 medical representatives graduated from this
representatives as well as the masters of
year’s Certificate of Medical Representative
ceremony, Mr. Marcus Wong of Servier and
course.
Ms Joann Wong of AstraZeneca for their contributions.
Talk on Internship Program to HKU and CUHK HKAPI members have always been active in providing training including clerkship and internship to pharmacy students and graduates in Hong Kong. Currently 10 member companies have been accredited by the Pharmacy and Poisons Board to provide 6-month internship to pharmacy graduates from HKU and CUHK. In order to let pharmacy students understand the operation of Research-based pharmaceutical companies in Hong Kong and the internship program designed for them, HKAPI and its member companies have organised a talk to HKU and CUHK on 24th November and 11th December respectively. During the talks, Ms. Sabrina Chan, Executive Director of HKAPI, first briefly presented the mission and the focus areas of the Association, participating HKAPI members then introduced their company background, highlighted the career pathway for pharmacists in different departments such as medical and regulatory affairs, clinical research. Details of the 6-month internship program were also provided and current interns were also present to share their working experience and what they have learnt during the internship. The Association would like to thank the support of AbbVie, AstraZeneca, GSK, and Roche for their informative presentations.
Ms. Sabrina Chan, Executive Director of HKAPI,
Ms. Rene Chau, Associate Medical Affairs
introduced the mission and the work of the
Manager of AstraZeneca.
Association.
Ms. Karen Yuen, Medical Director of AbbVie.
Ms. Emily Kam, Human Resources Manager of AbbVie.
Mr. Stephen Lee, Associate Director, ACE and
Mr. Ronald Leung, Regulatory Affairs Manager
Macau Business Unit, Roche.
of Roche and their current intern.
Mr. Donald Chong, Head of Regulatory and
Ms. Tina Chan, Head of Regulatory Affairs
Medical Affairs, GSK.
(Hong Kong & Macau Pharmaceuticals), GSK
HKAPI Bowling Cup 2015 (Click here for more photos) The annual HKAPI Bowling Cup was held on 13th November this year with great support from members. A total of 25 teams from member companies participated to compete for the championship as well as the individual award in the men's and women's division. Each team member bowled three games in the keen competition. The overall team championship finally went to MSD - Team A, with a high score of 2568, Sanofi - Team A and Pfizer were the 1st Runner up and 2nd Runner up respectively. In the individual division, Mr. Jonan Kwong of MSD won the men’s championship and the women’s division championship went to Ms. Irene Tai of Roche. Over 200 members and their family joined the event and cheered for their colleagues and enjoyed the exciting tournament. Results of the Bowling Cup
Men’s Division Champion: Jonan Kwong, MSD 1st Runner up: Sunny Wu, Pfizer 2nd Runner up: Nixon Nip, A. Menarini
Women’s Division Champion: Irene Tai, Roche 1st Runner up: May Ng, Merck Pharma 2nd Runner up: Doris Fung, MSD
Dr. Sian Ng, President of HKAPI (Middle), Mrs.
The Team's Champion goes to MSD, Dr.
Margaret Runpf (Right), HKAPI Vice President
Sian Ng presented the award to the team.
and Ms. Caroline Johnson (Left), General Manager of AbbVie, kick-started the tournament.
Ms. Michelle Kehily, Managing Director of
Ms. Caroline Johnson, General Manager of
MSD,
AbbVie, presented the prize to Women’s
presented
the
prize
to
Champion, Mr. Jonan Kwong of MSD.
Men’s
Champion, Ms. Irene Tai of Roche
25 teams competed for the championship in the Bowling Cup this year.
HKAPI Cup (Basketball) 2015 Finals (Click here for more photos) A total of 11 basketball teams participated in this year’s tournament, after several rounds of competitions that started in early September, the top six basketball teams that won the most number of matches entered into the finals and the plate championship which was held on 3rd December. Pfizer and Sanofi competed for the championship while Janssen and LF Asia competed for the second runner up. The competitions were very excited with many colleagues from our member companies cheering for their basketball teams. The champion finally goes to Pfizer and the second runner-up goes to Janssen. Results of the Basketball Cup Champion: Pfizer 1st Runner up: Sanofi 2nd Runner up: Janssen 3rd Runner up: LF Asia Plate Champion: Roche Plate 1st Runner-up: Boehringer-Ingelheim
The Champion goes to Pfizer, Mr. Stephen
The 1st Runner-up goes to Sanofi, Ms. Kelly
Leung, Country Manager of Pfizer
Lam, HKAPI Board of Director presented the
presented the award to the team.
award to the team.
The 2nd Runner-up goes to Janssen, Ms.
The 3rd Runner-up goes to LF Asia, Ms.
Sabrina Chan, Executive Director of HKAPI
Sabrina Chan presented the award to the
presented the award to the team.
team.
Highlights in the Finals: Pfizer vs Sanofi
Highlights in the Finals: Janssen vs LF Asia